# C_2007211EN.01002401.xml

| 8.9.2007 | EN | Official Journal of the European Union | C 211/24 |
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8.9.2007

EN

Official Journal of the European Union

C 211/24

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Action brought on 5 July 2007 — Commission of the European Communities v Republic of Austria

(Case C-311/07)

(2007/C 211/45)

Language of the case: German

Parties

Applicant: Commission of the European Communities (represented by: B. Stromsky and B. Schima, acting as Agents)

Applicant:

Defendant: Republic of Austria

Defendant:

Form of order sought

| — | Declare that the Republic of Austria has failed to fulfil its obligations under Article 6(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinaI products for human use and their inclusion in the scope of national health insurance systems (1), by failing to lay down a time-limit in accordance with that provision for the inclusion of medicinal products in the yellow or green sections of the ‘Erstattungskodex’ (Reimbursement Code); |
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Declare that the Republic of Austria has failed to fulfil its obligations under Article 6(1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinaI products for human use and their inclusion in the scope of national health insurance systems (1), by failing to lay down a time-limit in accordance with that provision for the inclusion of medicinal products in the yellow or green sections of the ‘Erstattungskodex’ (Reimbursement Code);

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| — | order the Republic of Austria to pay the costs. |
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order the Republic of Austria to pay the costs.

Pleas in law and main arguments

Directive 89/105/EEC aims, inter alia, to remove disparities in national measures of an economic nature which are adopted by the Member States in order to control public health expenditure on medicinal products. That includes measures to limit the range of products covered by national health insurance systems. In order to prevent such disparities from hindering intra-Community trade in medicinal products, the Directive lays down certain requirements in respect of the procedure for including products within the list of medicinal products covered by national health insurance systems. Accordingly, Article 6(1) of the Directive sets a time-limit for decisions on the inclusion of medicinal products in that ‘positive list’.

inter alia

In Austria, there are three different categories of reimbursement within the list of products covered by the health insurance system. The ‘green section’ covers medicinal products, the prescription and reimbursement of which without prior approval by the social security authority is appropriate and justified on medical and economic grounds. The costs of medicinal products listed in the ‘yellow section’ are reimbursed only in specific well-founded cases after prior approval by the social security authority. Finally, the ‘red section’ covers medicinal products in respect of which there is an application pending for inclusion in the yellow or green sections. The costs of medicinal products listed in the red section are reimbursed in specific well-founded cases after prior approval by the social security authority, provided that there is no alternative in the yellow or green sections. A valid application for inclusion of a medicinal product in the yellow or green sections of the Reimbursement Code thus necessarily means that that product is included in the red list for a certain period of time. Under the Austrian rules, medicinal products in the red section can remain in that section for no more than 24 months. If the average EU price cannot be established, the time-limit is extended to 36 months.

That rule is incompatible with Article 6(1) of Directive 89/10/EEC, because there is no guarantee that a decision on the inclusion of a medicinal product in the yellow or green sections, as required under that provision of the Directive, will be taken within 90 or 180 days.

As the Court of Justice held in its judgment of 12 June 2003 in Case C-229/00 Commission v Finland, the objectives of the Directive would be compromised if a Member State were able to introduce a dual procedure for the establishment of a list of medicinal products qualifying for higher-rate reimbursement, one pursuant to the obligations laid down by Article 6(1) of the Directive, the other being exempt in part from those obligations and, in part, not complying with the objectives laid down by that Directive. Contrary to the Austrian Government's view, it is not only applications for inclusion in a positive list, but also applications for inclusion in a particular category of such a list, that must be dealt with in accordance with the requirements of Article 6(1) of the Directive if, as in Austria, inclusion in that category entails more favourable conditions of reimbursement than inclusion in another category or remaining in the current category. Accordingly, it is necessary to ensure that decisions on such applications are taken within the period laid down under Article 6(1) of the Directive.

Commission

Finland

Since Austrian law does not make such provision, it is incompatible with the Community legislation referred to, having regard to the interpretation of that legislation by the Court of Justice.

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(1)  OJ 1989 L 40, p. 8.

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